Category: NICE CFS/ME guideline

ME Association: Updates: Blood Donation, XMRV and ME/CFS Version 3

Two further statements around the XMRV study have been issued by the ME Association (UK) and are published, in full, below this preamble:

“There is an immediate need for international agreement and co-operation on the research criteria being used to select well-characterised ME/CFS patients for further research into XMRV. Otherwise, we could end up in 2010 with a collection of conflicting results on prevalence because different international research groups have been using different patient selection criteria.

In the present situation, with many research groups reluctant or unwilling to use Canadian criteria, and not having stored samples from patients that meet Canadian criteria, the best way forward may be for everyone to agree to use Fukuda defined CFS. We may then be able to draw some conclusions about which people who come under the wide clinical spectrum of CFS clinical presentation have XMRV and which do not.”

Why is the MEA not recommending use of the more rigorous Canadian Criteria for replication studies?

Several years ago, the MEA held a formal postal ballot amongst its membership to vote for or against a proposal that the MEA should adopt the Canadian Criteria. Cases for and against adoption were published in the MEA’s magazine, ME Essential, with Dr Shepherd presenting the case against adoption. Of the very small percentage of the membership that returned a vote, the majority vote was in favour of adoption. The MEA announced the adoption “in principle” of the Canadian Criteria, then deftly kicked the Canadian Criteria under the carpet.

“…Demonstrating a link between a retrovirus and ME/CFS does not, by itself, resolve the physical vs psychological debate. Research studies have demonstrated links between retroviruses and diseases as diverse as autoimmune disorders (which could be relevant to ME/CFS), immunodeficiency diseases, multiple sclerosis, tumours, anaemias and even schizophrenia.”

I am not a member of the MEA; I was barred from membership of the Association in 2005 by Chair’s Action. A subsequent application to become a member of the Association was voted against by the Board of Trustees. The Association has the power, within the framework of its constitution, its Memorandum and Articles of Association, to deny membership to anyone it decides not to admit to membership [Clause 4.1 (b)]. Were I a member, however, I would be demanding an explanation from Dr Shepherd of what he means by the first sentence of the statement above.

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1] XMRV and blood donation – update following letter to the Chief Medical Officer (02.11.09)

2] XMRV and ME/CFS: WHAT DO WE KNOW SO FAR? AND WHAT DON’T WE KNOW? (VERSION 3) (04.11.09)

1] XMRV and blood donation – update following letter to the Chief Medical Officer (04.11.09)

http://www.meassociation.org.uk/content/view/1067/161/

XMRV and blood donation – update following letter to the Chief Medical Officer

The ME Association wrote to Sir Liam Donaldson, Chief Medical Officer at the Department of Health, on Tuesday 27 October about XMRV research. In particular, we raised the situation regarding people with ME/CFS and blood donation.

Click http://www.meassociation.org.uk/content/view/1059

to read a copy of this letter. An acknowledgement from the CMO has been received.

We are today writing to the CMO again to pass on the interim guidelines about blood donation and ME/CFS in America that have been issued by Dr John Niederhuber from the National Cancer Institute, US National Institutes of Health. This information was requested from the NCI by the CFIDS Association of America and has been published on their website:

http://www.cfids.org/temp/xmrv-guidelines-nci.asp

The MEA is very keen to build up an international database on the situation regarding blood donation and any information from people or support groups in other countries would be welcomed.

Following contact and discussions last week with a number of virologists and retrovirologists involved with XMRV research, the MEA will be updating our position statement on XMRV later in the week.

We shall also be repeating our offer to help fund good quality XMRV research here in the UK through the MEA Ramsay Research Fund:

http://www.meassociation.org.uk/content/view/30/205/

——————–

2] XMRV and ME/CFS: WHAT DO WE KNOW SO FAR? AND WHAT DON’T WE KNOW? (VERSION 3) (04.11.09)

http://www.meassociation.org.uk

Version 3 clarifies some of the points and queries raised in the previous two MEA statements and summarises the various actions now being taken by the ME Association.

It also updates the situation on XMRV research initiatives in the UK, testing for XMRV and refers to our letter to Sir Liam Donaldson, the Chief Medical Officer, regarding blood supplies and blood donation.

This summary is intended to be a balanced account which not only raises questions but is also very cautious when it comes to drawing any firm conclusions about the role of XMRV in ME/CFS at this very early stage in the research.

BACKGROUND

On Friday 9 October, the front page of the UK Independent newspaper carried a major news item under the heading ‘Has science found the cause of ME?’

This referred to new research findings from America which indicate that a recently discovered retrovirus, known as XMRV (xenotropic murine leukaemia virus-related virus), could be playing an important role in causing or maintaining ME/CFS. The news item was accompanied by a very supportive editorial about the need for recognition and research into ME/CFS. These two items can be read here:

http://www.meassociation.org.uk/content/view/1068/161/

The Independent story was soon followed up by the rest of the UK media, including the BBC. Most of the news reports gave a reasonably balanced and accurate account of the research. However, some reports incorrectly inferred that the cause of ME/CFS had now been conclusively discovered and that an effective antiviral treatment would soon be available. A selection of UK media reports can be found in the October news archive on the MEA website.

The actual research paper was published in the online edition of Science, along with a perspective written by John Coffin (Department of Molecular Microbiology, Tufts University, Boston, USA) and Jonathan Stoye (National Institute for Medical Research, London).

References:

Detection of an infectious retrovirus, XMRV, in blood cells of patients with chronic fatigue syndrome. Lombardi V et al. Science October 8 2009

http://www.sciencemag.org/cgi/content/abstract/1179052

Abstract

A new virus for old diseases? Coffin JM and Stoye JP. Science October 8 2009 326; p215

http://www.sciencemag.org/cgi/content/abstract/1181349

These papers are also available on the WPI website http://www.wpinstitute.org

Additional online data from the study can be obtained if required.

XMRV AND PROSTATE CANCER

XMRV has also been found in an American study in men who have prostate cancer. This was partly why the ME/CFS study was carried out. However, the most recent study on XMRV in prostate cancer from Germany has queried any such a link and suggested that one possible reason could be a geographically restricted incidence of XMRV infections. An additional explanation involves the type of laboratory testing for XMRV used in the two studies. The precise role of XMRV in prostate cancer remains uncertain.

Reference:

Lack of evidence for xenotropic murine leukaemia virus-related virus (XMRV) in German prostate cancer patients. Retrovirology 2009, 6:92. Available on-line here:

http://www.retrovirology.com/content/6/1/92

MEA POSITION ON XMRV

These are potentially important research findings that could help with both the diagnosis and management of ME/CFS. We congratulate all those involved in deciding to do this research study.

However, a number of difficult questions have to be answered before anyone can conclude that this virus plays a significant role in either the cause, transmission, clinical assessment or management of ME/CFS.

The research has demonstrated a correlation between ME/CFS and XMRV – not that it is the causative infection.

Much more epidemiology and laboratory work now needs to be done to answer the essential points set out below:

o Carrying out further and larger studies using different populations of people in different countries with ME/CFS. This work should include people at different stages of the illness (to see if the virus is present in the same percentages in both early and late cases) and in all degrees of severity. Research in different countries is vital in view of the conflicting geographical findings relating to XMRV in prostate cancer.

o Using different international laboratories to test for evidence of the virus.

o Establishing a battery of properly validated tests for XMRV that can be consistently used in further research studies.

o Assessing what, if any, correlation there is between the presence of this virus and (a) severity of symptoms, (b) a clear infectious onset with a known infection, (c) immune system abnormalities, CD4 abnormalities in particular, and (d) various other factors involved in sub-grouping of people under the ME/CFS umbrella.

o Assessing to what extent this particular retrovirus virus is also present in other chronic conditions, especially those such as autism, multiple sclerosis and lymphoma where viral infections have been implicated as a causative factor.

o Assessing whether this virus is acting as a benign marker of disease or immune dysfunction, is a ‘passenger virus’, or whether it has a role in the actual disease process and development of symptoms.

o Investigating whether the presence of the virus in healthy people acts as a predisposing factor in the development of ME/CFS (possibly when another infective trigger appears) and/or prostate cancer – rather than being involved in the actual disease process.

o Investigating what effect, if any, the virus has in healthy people who carry it over a period of time.

o Assessing whether people with evidence of XMRV should be treated with antiretroviral medication, and if so developing a suitable antiviral drug or combination of antiviral drugs.

o Assessing whether animal model studies would help to increase our understanding of the way in which this virus may infect cells and possibly cause human disease.

TESTING FOR XMRV IN THE UK AND USA

Until these research findings have been properly replicated, and we have the answers to some of the above questions, there is no point in asking your doctor to be tested for XMRV. This is because the NHS does not currently have the facilities to do so and the testing procedures are only being used in a research capacity at present. But, if it does turn out that there is a consistent and strong association with ME/CFS, then testing for XMRV would almost certainly have to be made available on the NHS.

We are not aware of any private pathology laboratories here in the UK that are able to test for XMRV, or are intending to start offering to carry out testing.

Dr Vincent Lombardi, primary investigator and lead author of the Science paper is Director of Operations for XMRV testing at Viral Immune Pathology Diagnostics VIPDx – a commercial laboratory in America. This testing facility is not available to people living outside the US.

VIRAL TRANSMISSION

We know that some people with ME/CFS are now very concerned about the possibility of transmission of XMRV through what are termed body fluids (ie blood, saliva, semen). However, until we know more about what this virus does in the body it would be premature to start arriving at firm conclusions and recommending all kinds of restrictions to normal daily living.

Remember: we still do not know for certain whether this is a disease-causing virus in humans and whether it plays a role in causing or maintaining ME/CFS.

And if this virus was behaving as an ‘ME virus’ in the way that HIV, another retrovirus, causes and transmits HIV infection, often leading to AIDS, there would be a significant number of sexual partners of people with ME/CFS developing ME/CFS. But this is clearly not the case.

One simple way of obtaining some early clues about viral transmission of XMRV would be to test for the presence of the virus in healthy partners and offspring of people who have the infection and comparing the findings to a control group of people that have no such link.

PRESENCE OF XMRV IN THE HEALTHY POPULATION

If this virus is also present in up to 4% of the normal healthy population here in the UK (ie around 2.4 million, or ten times the number of people who have ME/CFS), as appears to be the case in America, and it does play a significant role in diseases such as ME/CFS and prostate cancer, there will be widespread and very serious implications for public health, blood donation etc. This could also include vaccination against the virus and treating people who are XMRV positive. These are complex decisions which can only be made in the light of further research studies.

BLOOD DONATION AND XMRV

In relation to blood donation in the UK, current advice is that people with ME/CFS who have symptoms, or are receiving treatment, should not donate blood. It would seem sensible in the short term, until we know more about transmission and pathogenicity of XMRV, to consider extending this restriction to people who have recovered from ME/CFS. It seems strange that many overseas countries have not followed the UK lead on blood donation and ME/CFS.

The MEA has now written to Sir Liam Donaldson, Chief Medical Officer at the Department of Health, regarding the possibility of XMRV being transmitted via human blood products and the implications that this has for blood donation. A copy of this letter can be read here:

http://www.meassociation.org.uk/content/view/1059/

The CFIDS

Association of America has been issued with guidance from the National Cancer Institute regarding blood donation in the US. The guidance can be read on the CFIDS website:

http://www.cfids.org/temp/xmrv-guidelines-nci.asp

WHAT CAN WE LEARN ABOUT THE ROLE OF INFECTION FROM OUTBREAKS OF ME/CFS?

It should be noted that unlike the retroviral infection HIV, ME/CFS is an illness that occurs both sporadically and in highly localised acute geographical outbreaks, often involving closed communities such as schools and hospitals, where there is no obvious evidence of bodily fluid transmission. This fact would obviously question the role of XMRV as a precipitating infection in the onset of the illness.

In the pivotal Royal Free Hospital outbreak of ME back in 1955, far more than 4% of a previously healthy population of doctors and nurses contracted an unknown infection at roughly the same time (the hospital had to close due to lack of staff). This fact would question the role of XMRV as a key predisposing factor if it only occurs in 4% of the population.

TREATMENT OF XMRV: ANTIRETROVIRAL DRUGS AND VACCINE

Until we know more about the possible role of XMRV in ME/CFS there is no point in asking your doctor about antiviral drug treatment. If it turns out that the virus does play a role in causing or maintaining ME/CFS then antiviral drug treatment will need to be investigated. This will involve clinical trials to test possible drug treatments for both safety and efficacy – a process that normally takes a considerable amount of time and money.

The 2007 NICE Guideline on ME/CFS specifically states that doctors should not use antiviral medication to treat ME/CFS. This dogmatic position is unlikely to change without clear evidence of benefit in good quality randomised clinical trials. We understand that the NICE guideline will be reviewed in late 2010.

Vaccination against XMRV has also been raised as a possibility.

ROLE OF THE MEA RAMSAY RESEARCH FUND, VOLUNTEERING FOR RESEARCH and THE MEDICAL RESEARCH COUNCIL

The ME Association is keen to progress this research here in the UK through any way we can help. We have already made contact with virologists and retrovirologists who are interested in this virus here in the UK, and we are aware of at least four sound research groups who are keen to pursue this work. Funding from the Ramsay Research Fund (RRF) could be made available very quickly if we receive a good quality research proposal. However, our contacts and discussions with UK researchers so far indicate that short term funding is not an immediate problem and that initial plans can probably be covered from existing budgets.

More information on the work of the RRF can be found here:

http://www.meassociation.org.uk/content/view/30/205/

Since publication of these results it has become apparent that a number of international research groups outside the US and UK are also intending to try and confirm or refute the findings. The MEA has been contacted in relation to two such groups from overseas. This is obviously good news and should help to clear up some of the immediate uncertainties.

If volunteers are required for any research taking place in the UK we will place an announcement on the MEA website.

The Medical Research Council’s Expert Group on ME/CFS research (membership includes Dr Jonathan Kerr and Dr Charles Shepherd) will be holding a two day research workshop on 19 – 20 November where XMRV will obviously be one of the topics under discussion.

SELECTING PEOPLE FOR FURTHER RESEARCH STUDIES

There is an immediate need for international agreement and co-operation on the research criteria being used to select well-characterised ME/CFS patients for further research into XMRV. Otherwise, we could end up in 2010 with a collection of conflicting results on prevalence because different international research groups have been using different patient selection criteria.

In the present situation, with many research groups reluctant or unwilling to use Canadian criteria, and not having stored samples from patients that meet Canadian criteria, the best way forward may be for everyone to agree to use Fukuda defined CFS. We may then be able to draw some conclusions about which people who come under the wide clinical spectrum of CFS clinical presentation have XMRV and which do not.

Besides using stored blood samples, research needs to involve fresh clinical cases, as well as other disease groups (particularly inflammatory conditions with immune activation) and properly matched healthy controls.

KEY FACTS ABOUT THE XMRV RESEARCH

http://www.wpinstitute.org

o An American group from the Whittemore Peterson Institute, in collaboration with the National Cancer Institute and the Cleveland Clinic, have reported finding evidence of a human retrovirus known as XMRV in blood samples taken from people with ME/CFS.

o Using peripheral blood mononuclear cells, DNA (viral genetic material) from the virus was found in 67% of patients (68/101) compared to 3.7% in healthy controls (8/218).

o The XMRV virus was shown to grow in cell culture in the laboratory.

o Further studies have found that 95% of people with ME/CFS have antibodies to the virus – indicating an immune response to a recent or past infection.

o Blood samples were collected from people with what is referred to in the paper as CFS who live in different parts of the United States, as well as from healthy controls. More information on the patient and control cohorts can be found on the WPI website.

o A more detailed, but easy to understand, summary of the XMRV research has been prepared by Dr Suzanne Vernon for the CFIDS Association of America. This can be read at the CFIDS website. A press release summary produced by the National Cancer Institute is also worth reading:

http://www.cfids.org/cfidslink/2009/110402.asp

o The paper in Science does not provide any detailed information about the patient group (ie age, gender, illness characteristics) or control group. However, a report on the research published in The Wall Street Journal states that 20/101 people in the CFS group also had a lymphoma, a type of cancer affecting the lymph nodes. Questions have therefore been raised about the inclusion of these patients in the CFS group, as well as the makeup of the control group and how these patients were selected. See commentary from Professor Andrew Lloyd published on the website of the ME/CFS Society of NSW, Australia:

http://www.me-cfs.org.au/node/448

The WPI have now stated in a website response that none of the results in the Science paper relate to people with CFS plus lymphoma.

KEY FACTS ABOUT RETROVIRUSES

o Retroviruses infect a wide range of animal species.

o Human retroviruses consist of HIV (causing AIDS) , HTLV-1 (causing T-cell leukaemias and lymphomas) and HTLV-2 (often asymptomatic and not yet clearly linked to any specific disease).

o They were discovered in the 1980s when it became possible to culture T-cells in vitro.

o They infect CD4-bearing lymphocytes – a special type of immune system cell that is derived from the thymus gland.

o Endogenous retroviruses (ERVs) are also found in humans and usually cause no ill effects. Defective retroviruses which integrate into the host genome are passed down from generation to generation. And 2% of the human genome is made up of endogenous retroviral sequences.

o Retroviruses are enveloped viruses, with an RNA genome. The name retrovirus is derived from the fact that the virus particle contains an RNA-dependent DNA polymerase – reverse transcriptase. This enzyme converts the RNA genome into DNA, which then integrates into the host chromosomal DNA. The reverse transcriptase enzyme is highly error prone and rapid genetic variation is a feature of this group of viruses.

KEY FACTS ABOUT XMRV: Xenotropic murine leukaemia virus-related virus

o XMRV is a gammaretrovirus that was first described in 2006 in a group of men who had prostate cancer.

o It may also be linked to other medical conditions, including fibromyalgia.

o XMRV is closely related to a group of retroviruses that can infect mice.

o This type of virus is thought to be transmitted through body fluids such as blood, semen and breast milk. It is not thought to be transmitted through the air – like a flu virus. But the route of transmission remains uncertain.

o Testing for evidence of the XMRV virus in blood is currently only available at a few specialised laboratories here in the UK. Demonstrating a link between a retrovirus and ME/CFS does not, by itself, resolve the physical vs psychological debate. Research studies have demonstrated links between retroviruses and diseases as diverse as autoimmune disorders (which could be relevant to ME/CFS), immunodeficiency diseases, multiple sclerosis, tumours, anaemias and even schizophrenia.

CONCLUSIONS

The bottom line to this interesting research is that it currently raises more questions than answers.

o Does the presence of XMRV in healthy people make them more likely to develop ME/CFS when another infection appears?

o Does XMRV cause ME/CFS in some cases? Or does XMRV become active as a result of having ME/CFS?

o Or is it simply an innocent bystander with no role in the illness?

o Should XMRV be treated?

When we have accurate answers to at least some of these questions we can move forward, if necessary, with testing and treatment.

We will update this summary as further information becomes available.

If you want to comment on it please do so via the MEA Website.

Dr Charles Shepherd
Hon Medical Adviser, ME Association

Summary 3 dated 4 November 2009

ME in Parliament: Written Answers: 26 June, 1 July, 7 July 09

ME in Parliament: Written Answers: 26 June, 1 July, 7 July 09

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As circulated by Dr Marc-Alexander Fluks

Source: UK House of Commons
Date: June 26, 2009
URL: http://www.publications.parliament.uk/pa/cm200809/cmhansrd/cm090626/text/90626w0012.htm
Ref: http://www.me-net.combidom.com/meweb/web1.4.htm#westminster

[Written Answers]

Business, Innovation and Skills – Chronic Fatigue Syndrome

Lynne Jones

To ask the Minister of State, Department for Business, Innovation and Skills with reference to the answer to the right hon. Member for Horsham of 21 April 2008, Official Report, column 1785W, on chronic fatigue syndrome: research, when the Medical Research Council plans to set up a panel of experts from different disciplines to look at the subtypes and causes of myalgic encephalomyelitis/chronic fatigue syndrome. [281820]

Mr. Lammy

The Medical Research Council (MRC) set up in 2008 a panel of experts from different disciplines to look more closely at chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The group is reviewing the current research and will identify additional opportunities with the aim of stimulating further research into CFS/ME, in particular focusing on the causes of the condition. The MRC hopes that this will encourage new research towards understanding the aetiology and subtypes of CFS/ME and lead to an advancement of knowledge in this field and the development of new therapeutic approaches.

——————

Source: UK House of Commons
Date: July 1, 2009
URL: http://www.publications.parliament.uk/pa/cm200809/cmhansrd/cm090701/text/90701w0021.htm
Ref: http://www.me-net.combidom.com/meweb/web1.4.htm#westminster

[Written Answers]

Chronic Fatigue Syndrome

Mr. Greg Knight

To ask the Secretary of State for Health (1) what recent assessment he has made of his Department’s guidelines for the treatment of myalgic encephalopathy compared to international best practice; [283105] (2) what recent representations he has received on the revision of treatment guidelines for myalgic encephalopathy issued to trusts by his Department. [283106]

Ann Keen

The Department has not issued guidelines for the treatment of myalgic encephalopathy. Guidelines for the diagnosis and management of chronic fatigue syndrome/myalgic encephalomyelitis were published in 2007 by the National Institute for Health and Clinical Excellence. They would have responsibility for revising this guidance.

——————

Source: UK House of Commons
Date: July 7, 2009
URL: http://www.publications.parliament.uk/pa/cm200809/cmhansrd/cm090707/text/90707w0031.htm
Ref: http://www.me-net.combidom.com/meweb/web1.4.htm#westminster

[Written Answers]

Chronic Fatigue Syndrome

Lynne Jones

To ask the Minister of State, Department for Business, Innovation and Skills pursuant to the answer of 26 June 2009, Official Report, columns 1198-99W, on chronic fatigue syndrome, who the members of the panel of experts are; and how often it has (a) met and (b) reported on its findings. [283743]

Mr. Lammy

The membership of the expert group set up by the Medical Research Council is as follows:

Professor Jill Belch (Chair) – University of Dundee,
Professor Stephen Holgate – University of Southampton,
Dr. Esther Crawley – University of Bristol,
Professor Philip Cowen – University of Oxford,
Professor Malcolm Jackson – University of Liverpool,
Dr. Jonathan Kerr – St George’s University of London,
Professor Ian Kimber – University of Manchester,
Professor Hugh Perry – University of Southampton,
Dr. Derek Pheby – National CFS/ME Observatory,
Professor Anthony Pinching – Pennisula Medical School,
Dr. Charles Shepherd – ME Association,
Sir Peter Spencer – Action for ME,
Professor Peter White – Bart’s and the London School of Medicine and Dentistry.

The Expert Group has met twice, in December 2008 and March 2009. The notes of those meetings will be published on the MRC website shortly, and will then be accessible to the public.

————-

Notes:

1] For Minutes of the December 08 meeting of the MRC “CFS/ME Expert Group” see previous posting: MRC Two day Research Workshop 19 and 20 November 2009: http://wp.me/p5foE-2bS.

Minutes for the March 09 meeting have not yet been published.

2] The MRC “CFS/ME Expert Group” is chaired by Professor Stephen Holgate.

3] No Agenda or list of partipants has been issued for the two day MRC “CFS/ME Expert Group” scheduled for 19 – 20 November. I have submitted a request to the MRC for information under the FOIA for a copy of the Agenda, the list of participants and for clarification of whether the MRC “CFS/ME Expert Group” anticipates holding further meetings beyond the November workshop.

4] The NICE Guideline for CFS/ME (CG 53) is currently scheduled for review in August 2010.

Dr Nigel Speight resigns from children and young person’s organisation AYME

Dr Nigel Speight resigns from the children and young person’s organisation AYME

For many years, paediatric specialist, Dr Nigel Speight, has been a champion of families with a child or young person with ME or where ME is suspected.

He has advocated for families facing wrongful accusation of MSpB (FII), where child protection orders have been instigated or threatened following disagreements between the family and the child’s medical professionals over the management of the condition, where medical professionals have been unwilling to make a diagnosis of ME and where social services have become involved in the case when a child or young person has been unable to regularly attend mainstream school due to ill health.

Dr Speight recently announced his resignation as a Patron to the children and young person’s patient organisation, AYME [Association of Young People with ME] http://www.ayme.org.uk/.

AYME’s Medical Advisor is Dr Esther Crawley, Consultant Paediatrician at the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust. Dr Crawley had been a member of the NICE CFS/ME Guideline Development Group.

Dr Speight, who is now retired from the NHS, has become a Medical Advisor to the 25% M.E. Group.

The following announcement was published in a recent 25% M.E. Group newsletter:

I just thought I should inform you officially that after a long and happy association with AYME I have decided to resign as their Patron. Without going into too much detail I would say that over the last couple of years I have become aware that they have changed their position on several areas and that our views have accordingly diverged. In particular AYME seem to have become more willing to collaborate with the medical and psychiatric establishment in order to appear respectable. This appears to have been the cause of AYME’s relative enthusiasm for the NICE Guidelines, which most of us feel involve an overemphasis on CBT and GET. This compromise seems to have helped the psychiatrists to get a new lease of life.

The result of all this is that AYME appear to have alienated themselves from most of the other ME charities (with the exception of AfME [Action for M.E.] who appear to be taking a similar position). In this controversy I feel more in sympathy with the rest of you. I have gained the impression that AYME no longer appreciate my opinions and prefer my status as their figurehead to be a largely silent one. It is a combination of all these factors that has caused me to resign and I am sure you will all understand.

With Best Wishes

Nigel Speight

Revised MEA statement on retrovirus XMRV and ME/CFS

Revised MEA statement on retrovirus XMRV and ME/CFS

WordPress Shortlink: http://wp.me/p5foE-2cD

http://www.meassociation.org.uk/content/view/1051/161/

RETROVIRUS XMRV and ME/CFS: WHAT DO WE KNOW SO FAR? AND WHAT DON’T WE KNOW? (VERSION 2)

This is a considerably extended and updated version of our first summary on XMRV research. It includes additional information relating to questions that are coming to the MEA about the research findings, in particular questions concerning possible transmission and spread of XMRV, availability of private and NHS tests for the virus here in the UK, possible treatment of XMRV with antiviral drugs, and volunteering for UK research studies. We also report on a new research study from Germany that has queried the link between XMRV and prostate cancer.

This summary is intended to be a balanced account which not only raises questions but is also very cautious when it comes to drawing any firm conclusions about the role of XMRV at this very early stage in the research.

BACKGROUND

On Friday 9 October, the front page of the UK Independent newspaper carried a major news item under the heading ‘Has science found the cause of ME?’ This referred to new research findings from America which indicate that a recently discovered retrovirus, known as XMRV (xenotropic murine leukaemia virus-related virus), could be playing an important role in causing or maintaining ME/CFS. The news item was accompanied by a very supportive editorial about the need for recognition and research into ME/CFS. These two items can be read here

The Independent story was soon followed up by the rest of the UK media, including the BBC. Most of the news reports gave a reasonably balanced and accurate account of the research. However, some reports incorrectly inferred that the cause of ME/CFS had now been conclusively discovered and that an antiviral treatment would soon be available. A selection of UK media reports can be found in the October news archive on the MEA website.

References:

Detection of an infectious retrovirus, XMRV, in blood cells of patients with chronic fatigue syndrome. Lombardi V et al. Science October 8 2009 Abstract: http://www.sciencemag.org/cgi/content/abstract/1179052

A new virus for old diseases? Coffin JM and Stoye JP. Science October 8 2009 326; p215 Abstract:
http://www.sciencemag.org/cgi/content/abstract/1181349

Additional online data from the study can be obtained if required.

Reference:

Lack of evidence for xenotropic murine leukaemia virus-related virus (XMRV) in German prostate cancer patients. Retrovirology 2009, 6:92. Available on-line: http://www.retrovirology.com/content/6/1/92

MEA POSITION

These are potentially important research findings that could help with both the diagnosis and management of ME/CFS. We congratulate all those involved in deciding to do this research study.

However, a number of questions still have to be answered before anyone can conclude that this virus plays a significant role in either the cause, transmission, clinical assessment or management of ME/CFS.

The research has demonstrated a correlation between ME/CFS and XMRV – not that it is the causative infection.

Much more epidemiology and laboratory work now needs to be done to answer the essential points set out below:

◦ Carrying out further and larger studies using different populations of people in different countries with ME/CFS. This work should include people at different stages of the illness (to see if the virus is present in the same percentages in both early and late cases) and in all degrees of severity. Research in different countries is vital in view of the conflicting geographical findings relating to XMRV in prostate cancer.

◦ Using different international laboratories to test for evidence of the virus.

◦ Assessing what, if any, correlation there is between the presence of this virus and (a) severity of symptoms, (b) a clear infectious onset with a known infection, (c) immune system abnormalities, CD4 abnormalities in particular, and (d) various other factors involved in sub-grouping of people under the ME/CFS umbrella.

◦ Assessing to what extent this particular retrovirus virus is also present in other chronic conditions, especially those such as multiple sclerosis and lymphoma where viral infections have been implicated as a causative factor.

◦ Assessing whether this virus is acting as a benign marker of disease or immune dysfunction, or is a ‘passenger virus’, or whether it has a role in the actual disease process and development of symptoms.

◦ Investigating whether the presence of the virus in healthy people acts as a predisposing factor in the development of ME/CFS (possibly when another infective trigger appears) and/or prostate cancer – rather than being involved in the actual disease process.

◦ Investigating what effect, if any, the virus has in healthy people who carry it over a period of time.

◦ Assessing whether people with evidence of the virus should be treated with antiretroviral medication, and if so developing a suitable antiviral drug or combination of antiviral drugs.

◦ Assessing whether animal model studies would help to increase our understanding of the way in which this virus may infects cells and possibly cause disease.

TESTING FOR XMRV

Until these research findings have been robustly replicated, and we have the answers to some of the above questions, there is no point in asking your doctor to be tested for XMRV. This is because the NHS does not currently have the facilities to do so and the testing procedures are only being used in a research capacity at present. But if it does turn out that there is a consistent and strong association with ME/CFS then testing for XMRV would almost certainly have to be made available.

We are not aware of any private pathology laboratories here in the UK that are able to test for XMRV, or are intending to start offering this test. Private testing is available in some countries outside the UK.

VIRAL TRANSMISSION

PRESENCE OF XMRV IN THE HEALTHY POPULATION

If this virus is also present in up to 4% of the normal healthy population here in the UK (ie around 2.4 million, or ten times the number of people who have ME/CFS), as appears to be the case in America, and it does play a significant role in diseases such as ME/CFS and prostate cancer, there will be widespread and very serious implications for public health, blood donation etc. This could also include vaccination against the virus and treating people who are XMRV positive. But these are complex decisions which can only be made in the light of further research studies.

WHAT CAN WE LEARN ABOUT THE ROLE OF INFECTION FROM OUTBREAKS OF ME/CFS?

It should be noted that unlike the retroviral infection HIV, ME/CFS is an illness that occurs both sporadically and in highly localised acute geographical outbreaks, often involving closed communities such as schools and hospitals, where there is no obvious evidence of bodily fluid transission. This fact would obviously question the role of XMRV as a precipitating infection in the onset of the illness.

In the pivotal Royal Free Hospital outbreak of ME, far more than 4% of a previously healthy population of doctors and nurses contracted an unknown infection at roughly the same time (the hospital had to close due to lack of staff). This fact would question the role of XMRV as a key predisposing factor if it only occurs in 4% of the population.

TREATMENT OF XMRV

ROLE OF THE MEA RAMSAY RESEARCH FUND and VOLUNTEERING FOR RESEARCH

The ME Association is keen to progress this research here in the UK through any way we can help. We have already made contact with virologists who are interested in this virus here in the UK and funding from the Ramsay Research Fund (RRF) could be made available very quickly if we receive a good quality research proposal.

More information on the work of the RRF can be found here

Since publication of these results it has become apparent that a number of international research groups are intending to try and confirm or refute the findings. The MEA has been contacted in relation to four such groups already – two from overseas. This is obviously good news and should help to clear up some of the immediate uncertainties.

If volunteers are required for any research taking place in the UK we will place an annoucement on the MEA website.

KEY FACTS ABOUT THE XMRV RESEARCH

◦ An American group from the Whittemore Peterson Institute, in collaboration with the National Cancer Institute and the Cleveland Clinic, have reported finding evidence of a human retrovirus known as XMRV in blood samples taken from people with ME/CFS.

◦ Using peripheral blood mononuclear cells, DNA (viral genetic material) from the virus was found in 67% of patients (68/101) compared to 3.7% in healthy controls (8/218).

◦ The XMRV virus was shown to grow in cell culture in the laboratory.

◦ Further studies have found that 95% of people with ME/CFS have antibodies to the virus – indicating an immune response to a recent or past infection.

◦ Blood samples were collected from people with what is referred to in the paper as CFS who live in different parts of the United States, as well as from healthy controls.

◦ A more detailed, but easy to understand, summary of the XMRV research has been prepared by Dr Suzanne Vernon for the CFIDS Association of America. This can be read on their website: www.cfids.org/cfidslink/2009/110402.asp

◦ The paper in Science does not provide any detailed information about the patient group (ie age, gender, illness characteristics) or control group. However, a report on the research published in The Wall Street Journal states that 20/101 people in the CFS group also had a lymphoma, a type of cancer affecting the lymph nodes. Questions have therefore been raised about the inclusion of these patients in the CFS group, as well as the make up of the control group and how these patients were selected. See commentary from Professor Andrew Lloyd published on the website of the ME/CFS of NSW, Australia: www.me-cfs.org.au/node/448

KEY FACTS ABOUT RETROVIRUSES AND XMRV

◦ Retroviruses are a small group of human viruses that consist of HIV (causing AIDS) , HTLV-1 (causing T-cell leukaemias and lymphomas) and HTLV-2 (often asymptomatic not yet clearly linked to any specific disease).

◦ They were discovered in the 1980s when it became possible to culture T-cells in vitro.

◦ They infect CD4 bearing lymphocytes – a special type of immune system cell that is derived from the thymus gland.

◦ Endogenous retroviruses (ERVs) are also found in humans and usually cause no ill effects.

◦ XMRV is retrovirus that was first described about three years ago in some men who have prostate cancer.

◦ It may also be linked to other medical conditions, including fibromyalgia.

◦ XMRV is related to a group of viruses that can infect mice.

◦ This type of virus is thought to be transmitted through body fluids such as blood, semen and breast milk. It is not thought to be transmitted through the air – like a flu virus.

◦ Testing for evidence of the XMRV virus in blood is currently only available at a few specialised laboratories here in the UK.

◦ Demonstrating a link between a retrovirus and ME/CFS does not, by itself, resolve the physical vs psychological debate. Research studies have demonstrated links between retroviruses and diseases as diverse as autoimmune disorders (which could be relevant to ME/CFS), immunodeficiency diseases, multiple sclerosis, tumours, anaemias and schizophrenia.

CONCLUSION

The bottom line to this interesting research is that it currently raises more questions than answers.

◦ Does the presence of XMRV in healthy people make them more likely to develop ME/CFS when another infection appears?
◦ Does XMRV cause ME/CFS in some cases?
◦ Does XMRV become active as a result of having ME/CFS?
◦ Or is it simply an innocent bystander with no role in the illness?
◦ Should XMRV be treated?

When we have accurate answers to at least some of these questions we can move forward, if necessary, with testing and treatment.

We will update this summary as further information becomes available.

If you want to comment on it please do so via meconnect@meassociation.org.uk

Dr Charles Shepherd
Hon Medical Adviser, ME Association

Summary 2 dated 22 October 2009

Times Letters: British intervention in healthcare debate in the US and our NHS

In response to the report “David Cameron turns on MEP Daniel Hannan for anti-NHS tour in America” Times Online, 14 August, H Patten has a letter published today in the print and online editions:

Times Letters

http://www.timesonline.co.uk/tol/comment/letters/article6798223.ece

The Times
August 17, 2009

‘Untruths’ about NHS system of healthcare
British intervention in the healthcare debate in the US and our NHS

Sir, The quarter of a million sufferers of myalgic encephalomyelitis (ME) in this country, who can access no effective NHS treatment for their physical illness, might agree with Mr Hannan in that they would not wish their NHS “care” on anybody.

ME has been classified as a physical, neurological illness (alongside MS and Parkinson’s) by the World Health Organisation since 1969. Instead of receiving biomedical treatment, ME sufferers are mixed up with sufferers of other fatigue-causing conditions, including mental ones, under the meaningless umbrella term “chronic fatigue syndrome”. In the UK no other neurological illness is treated solely by psychological interventions.

All UK taxpayers’ research and treatment millions have gone to the psychiatric profession that insist, against all scientific evidence, that it is an “abnormal illness belief”. No funding has ever been allotted to developing a diagnostic test. The parliamentary Gibson report recommended that these psychiatrists be investigated for a possible conflict of interest in also working for large insurance companies. This has never been done. Is healthcare here also, in President Obama’s words, “working better for the insurance companies” than for ME sufferers?

H. Patten

Frome, Somerset

RiME: Summary APPG on ME meeting 8 July 2008

Permission to Repost

Campaigning for Research into ME (RiME) www.rime.me.uk

Summary of APPG on ME Meeting 8/7/09

Meeting started 1.30pm

Politicians present: Des Turner MP, Andrew Stunell MP, Peter Luff MP; Lady Mar.

AGM

It was decided that Lady Mar would replace Ian Gibson as Secretary; otherwise the line-up stays the same:

Chair – Des Turner MP, Vice-Chairs – Tony Wright MP + Andrew Stunell MP, Treasurer – David Amess MP.

Inquiry

Paul Davis RiME raised concerns about objectivity, reminding people that the Gibson Report signed by Des Turner and Lady Mar says:

(A) ‘The £8.5m ring fenced by the DOH was used.. to set up 13 new CFS/ME treatment centres nationwide… The Group is extremely pleased with the advent of these centres and we hope they will be maintained and rolled out’ (5.1.) (B) that they were to his (Wessely’s) model (3.2)

In addition, you (Turner) said at the APPG meeting 2/7/08 you expected the inquiry would be taking evidence on progress ( – ed?) made since the CMO Report in January 2002.

Many ME patients, I said, would say that matters had regressed since the publication of the CMO Report 2002.

Were you not being precocious Dr Turner?

If I remember correctly, Turner looked at Lady Mar, seemed to laugh, and then mutter something I couldn’t hear.

On a wider note, Paul Davis mentioned the services in Sussex saying ‘you are patron of the Sussex Group Dr Turner, which supports the clinics in Sussex, yes?’ Turner nodded.

Davis – Patients accepted as referrals into the Sussex CFS/ME MDT need to fulfil the following criteria….

• The patient is willing to have a biopsychosocial and management assessment

(this in turn is based on the CNCC at Barts London, which says under Referral Criteria, ‘The patient is willing to have a biopsychosocial assessment’).

So, in addition to recognising ME to be a neurolgical illness under G93.3 (as APPG Chair) do you also deem it, in part at least, psychosocial? Is that not contradictory? (see Overview of meeting – below).

At this point, Dr Turner turned again to Lady Mar; they smiled; and if I caught what he muttered, said something about he couldn’t see a problem and isn’t there a psychosocial element to all illnesses?

(Gus Ryan/Ciaran Farrell notes say that Turner said that the Sussex Group were not keen on the Inquiry as they were psychosocially minded).

Janice Kent ReMember said something quietly to do with the Sussex Services which I couldn’t hear.

Jill Cooper West Midlands ME Groups Consortium pointed out that evidence sent to Inquiry wasn’t being acknowledged. I concurred.

Charles Shepherd MEA said there was a lack of publicity re. Inquiry.

2.00pm Turner left, followed by Stunell and Luff. Lady Mar chaired rest of meeting.

Peter Spencer AfME: We have to recognise that the decision taken at last meeting to drive ahead with timescales was taken in the knowledge that the Inquiry is not going to be as high-quality or as comprehensive as some had aspired to… The concern people have that the work may be of such poor quality as to be of no value is a real one… I hope that a report will come out which has sufficient credibility, a sufficient evidence base and sufficient authority from the parliamentarians to make it something that the Health Select Committee might want to take up, where there will be a much more thorough investigation. That is a realistic ambition.

Jill Cooper said an endocrinologist runs the ME clinic in Warwickshire (Nuneaton) and people are concerned that if there is no further funding the clinic may not continue to run.

Michelle Goldberg thought Dr William Weir should be involved in the process. Shepherd pointed out that he was in private practice now.

Statement form WMMEG (West Midlands ME Groups Consortium)

Jill Cooper: Can the Secretariat confirm that copies of the correct statement have been sent to attendees of the April meeting? Heather Walker AfME said they had.

Cooper: The key issues outlined of CCNRC Transparancy & Accountability remain unresolved. Whilst we would always advocate measured & constructive dialogue, without transcripts/DVD etc pwME & local groups cannot possibly judge whether the perceived “benefits” of being a “critical friend” as advocated by AfME & AYME, is actually supported by any tangible evidence that it is benefitting pwME and their families?

We would like sufficient time to be allocated to discuss this key issue of appropriate NHS education & training at a future APPG meeting: No point in people clamouring for more NHS resources if staff are being centrally “trained” to view ME/CFS as a psychosomatic illness.

Spencer said AfME would remain a critical partner with the NHS. Stephen Holgate MRC, he said, understood the frustration of ME patients; there were efforts to get new research talent into the field; talk of developing a tissue archive.

Lady Mar said her message about the problems with Pathways to Work is getting through.

Future of the APPG

Lady Mar said the future of the APPG is up in the air due to the impending General Election.

Future Work

Jane Colby TYMES: follow up was needed re. children being sectioned. Spencer, how? Lady Mar said get Inspector of Social Services involved.

Christine Harrison said the DWP Welfare to Work is still an issue

Legacy Paper

Spencer raised the idea of an APPG consensus document – outstanding concerns, obectives…

Shepherd said this was admirable but wanted input from MEA.

Meeting closed 2.36pm.

Disclaimer: The above is based largely on my scribbled notes. I cannot guarantee 100% accuracy. It is a summary, not a verbatim account.

Overview

This was the smallest gathering I have witnessed (probably to do with Inquiry oral sessions starting the next day – good planning eh?); and the shortest meeting.

At these meetings, there is not always the opportunity to pursue a line of enquiry. Sometimes the meeting moves on… Following my question to Dr Turner, ‘is that not contradictory’ (see above) – if I remember correctly (1) Janice Kent said a few words, then (2) I did get a point in that ‘treatment’ seems to be essentially psychosocial but not bio.

Those familiar with RiME will know what I am driving at. For the less initiated: Myalgic Encephalomyelitis (ME) is recognised by the World Health Organisation, eminent scientists, the APPG even, as a neurological illness. But the British Government has not spent a single penny investigating what is causing/perpetuating this dreadful neurological illness. Instead, it put bits of chicken-feed into psychosocial models of treatment. A cheap option, of course. Scandalous.

What is the APPG doing about it? Nothing, it would appear. The Gibson Report which Dr Turner + Lady Mar signed up to has been and gone. If the primary aim of the latter was to effect publicly funded biomedical ME Research, it failed; and there was no plan B. The APPG then, it would seem, has given up on that front.

If the APPG was genuinely about trying to help people with G93.3 ME would it not be lobbying vigorously for biomedical research? There would appear to be nothing to suggest it is. Instead, what is it doing? Holding an Inquiry into clinics which practice psychosocial models of ‘treatment’. Clincs which, throughout England, are being condemned by ME parties. Extremely disappointing, to say the least. Who, at this stage, would bet against it manufacturing a report favorable to the clinics set up following CMO Report? APPG officials have already demonstrated support for the clinics (see website, NHS Services Inquiry folder, RiME Comment May 27 file).

Re Inquiry: Thanks to those groups and individuals who sent copies of written evidence for RiME bank (over 50 so far). More on this soon. Those who contacted RiME saying they couldn’t participate on principle, we respect your decision. I would say the general consensus is that the APPG on ME is not working in the interests of ME patients; indeed, many would say it is working against them.

Paul Davis
rimexx@tiscali.co.uk

www.rime.me.uk

Concerning a recent statement and report published in the wake of the Judicial Review of the NICE Guidelines on CFS/ME

Concerning a recent statement and report published in the wake of the Judicial Review of the NICE Guidelines on CFS/ME

1 August 2009

In the past two days, various material has been published on the internet in relation to matters arising out of the Judicial Review of the NICE Guidelines on CFS/ME which was heard in the High Court in February, this year.

This includes a statement issued on behalf of Professor Malcolm Hooper and Margaret Williams.

The statement discloses that in April 2009 a “substantial complaint” was served on the legal representatives for the Fraser/Short legal challenge – a complaint said to be currently before the Legal Complaints Service and the Bar Council Standards Board and the subject of on-going action.

The Statement from Professor Malcolm Hooper has been published by Stephen Ralph, on Professor Hooper’s behalf, on Co-Cure and on ME Action UK site and is dated 29 July 2009. A second statement issued by Professor Hooper was published on 5 August.

On 30 July, Jane Bryant, Director of the ONE CLICK Group and the Interested Party’s Litigant Friend in the Judicial Review, published a report and commentary on the ONE CLICK Group site. Selected court documents were also placed in the public domain on 30 July which form an integral part of the report and which need to be read in conjunction with this report.

The report reveals that following the Judicial Review hearing, Beachcroft LLP, the solicitors acting for NICE, submitted a Wasted Costs Application which was granted by the High Court and that in June 2009, Leigh Day & Co were served with a Wasted Costs Order of £50,000, payable to the Defendants, NICE.

As some of the issues set out and discussed within the statements, the report and associated court documents relate to the “substantial complaint” and “on-going action” against the legal representatives who had acted for the Claimants, Mr Douglas Fraser and Mr Kevin Short, I am not intending to publish the statements from Professor Malcolm Hooper of 29 July and 5 August, nor the report and commentary by Jane Bryant of 30 July.

I refer readers, instead, to the respective websites of those who have published this material.

The statement appended has been published elsewhere, today, by two individuals who were not involved in either the case for the Defendants or that of the Claimants and the Interested Party, but who wish to clarify their respective positions, in the light of recent events.

Previous postings around the NICE CFS/ME Judicial Review are archived under Category tag NICE Judicial Review

COURT JUDGMENT Document for hearing 11 and 12 February 2009 in PDF format here: Approved NICE Judgment [1.3MB]

NICE PRESS STATEMENT ISSUED: 13 MARCH 2009

NICE statement on CFS/ME judicial review outcome

http://www.nice.org.uk/media/001/6F/CFSMEJRJudgementStatement130309.pdf

or open PDF here: cfsmejrjudgementstatement130309

The Expected Review Date for NICE G53 is currently given as August 2010.

——————

For BMJ Rapid Responses to NICE related articles and Letters

See: http://www.bmj.com/cgi/eletters/338/jun04_3/b1805#217952

for Rapid Responses to:

PRACTICE:
Pauline Savigny, Paul Watson, Martin Underwood on behalf of the Guideline Development Group
Early management of persistent non-specific low back pain: summary of NICE guidance

(Tom Kindlon, Information Officer, Irish ME/CFS Association)

and http://www.bmj.com/cgi/eletters/339/jul28_3/b3028

for Rapid Responses to:

LETTERS:
Michael Rawlins and Peter Littlejohns
NICE outraged by ousting of pain society president

(Tom Kindlon, Information Officer, Irish ME/CFS Association; Dr Ellen Goudsmit)

Permission to repost

CLARIFICATION BY ANGELA AND STEPHANIE KENNEDY

In light of recent events and suggestions made elsewhere about both of us, we would like to clarify, collectively, the following:

In 2005, Stephanie, after receiving a ‘CFS/ME’ diagnosis in 2001/2002, was subsequently given a ‘borreliosis’ diagnosis, following test results. As anyone with any knowledge of the problems facing people diagnosed with ‘CFS/ME’, or ‘Lyme’, or ‘borreliosis’ will understand, the political situation is not as simple as being diagnosed with one or another. A useful account, for the layperson, of the rank confusion and contestation surrounding ‘Lyme’, ‘borreliosis’ and ‘CFS’ diagnoses is given in Pamela Weintraub’s book “Cure Unknown: Inside the Lyme Epidemic”, with a foreword by Hilary Johnson, author of “Osler`s Web”. It should be noted that many people, initially diagnosed with ‘CFS/ME’, have subsequently received a diagnosis of ‘borreliosis’ or ‘Lyme’, or other condition or disease.

Stephanie remains severely physiologically impaired by her condition, though there have been small improvements due to certain treatments and a proper diagnosis of a cardiac/neurological condition. We would both like to go on record and say, specifically, that none of this improvement has been as a result of NHS policy or ‘care’. Our collective position remains that the NICE guidelines are inappropriate and dangerous.

In 2007, Stephanie attempted to bring, independently from any other party, a Judicial Review against NICE in respect of their Guidelines for ‘CFS/ME’. Because of the other, apparently partially funded, cases being brought at the same time, Stephanie could not secure Legal Aid and therefore unfortunately could not proceed. Situations such as these are apparently quite common and neither of us hold anyone ‘responsible’ for Stephanie’s failure to secure Legal Aid.

Another clarification we need to make is that we had no knowledge of the Short/Fraser case until it was first announced publicly, although it is clear they had knowledge of Stephanie’s case as her solicitors were mentioned by Professor Malcolm Hooper in his statement. Although we kept the One Click group informed of Stephanie’s intention to bring a JR action, we were not given any information by them, and therefore had no knowledge of the One Click JR case apart from that made public by them.

We are both keen to see accuracy prevail, because we believe there are important advocacy lessons that might be learned from a careful analysis of what has happened. For this reason we may have cause to clarify any further issues raise by public comments made by supporters of the Short/Fraser or the One Click JR action.

Due to family problems at the time, Angela was unable to continue campaigning with the One Click Group. Since April 2006, the trajectory of campaigning that One Click has subsequently taken is therefore not that of Angela’s own, although Angela is aware that some of her work was used by One Click in the response to the NICE guidelines (for example, her “Summary of the Psychiatric Paradigm of ME/CFS” document), subsequent to her having discontinued her association with them. Angela has no problem with her previous work on either NICE or the psychiatric paradigm being used by other advocates, and is happy that this work has been of use to people.

Since leaving One Click in 2006, Angela continues to work in advocacy for people suffering because of ‘psychogenic’ explanations for their illness. For example, she co-initiated a campaign to ensure the APPG on ME were made fully aware of the objections many in the ME/CFS community have to the ‘psycho-social’ approach adopted by most of the ‘CFS/ME’ clinics. This was done in support of other advocates who had been highlighting this problem. In 2008 she, with another advocate, tackled the ongoing misrepresentation of the ME/CFS community that was taking place on Wikipedia, an unfortunate result of unsubstantiated allegations, made in the Gibson Report, about members of the ‘CFS/ME’ community ‘harassing’ a Professor. As a result of their attempts to protect the ME/CFS community from such unsubstantiated allegations being incorporated into the Wikipedia article on Simon Wessely, Angela was herself defamed on Wikipedia, and, falsely implicated as being involved in “personally harassing” Professor Wessely. More information on this subject can be found here in the public-archived dedicated Yahoo Group APK-Papers.

Angela continues to advocate for people adversely affected by the scientific and logical flaws in ‘psychogenic’ explanations for illness. She is currently working on an academic project which she hopes will benefit the ME/CFS, Lyme and other patient communities, a project supported by Stephanie. Both continue to support the work of other patient advocates whenever possible.

We both hope that the above clarifies our respective positions.

ANGELA KENNEDY
STEPHANIE KENNEDY

1 August 2009

RSM “Medicine and me” event: Commentary by John Sayer

Royal Society of Medicine “Medicine and me” event on ME and CFS held Saturday, 18 July 2009

Commentary

John Sayer (Chair, M.E. Support-Norfolk)

25 July 2009

The half-day conference was organised jointly by the Royal Society of Medicine, the MEA, AfME, AYME, the 25% ME Group and TYMES Trust.

The promotional literature informed us that:

“‘Medicine and me’ conferences, initiated and developed by the Royal Society of Medicine, are specifically designed for patients. These meetings bring together patients, their families, carers, advocates, patient support groups, clinicians and researchers to discuss care and research issues in a particular condition…[and]…aim to provide a forum in which patients’ concerns about their illness are given top priority.”

Unfortunately, the pattern of the day – two presentations at a time followed by a five-minute slot for questions – did not really provide for much in the way of patient-led questions and/or discussion. It was, however, an opportunity to see what the various bodies involved had to say for themselves (and encouraging to hear Jane Colby of TYMES Trust underline in her welcome address that the title of the proceedings was “Medicine and me: ME *and* CFS”).

(This write-up is based on notes taken at the time by myself and Gus Ryan.)

Session 1 was chaired by Dr Charles Shepherd (MEA), who reminded us that there had been two parliamentary meetings [i.e. the All-Party Parliamentary Group on ME and the Countess of Mar’s ForwardME Group] earlier in the week and that people still had a chance to submit written evidence to the APPGME’s NHS service provision inquiry.

Dr Abhijit Chaudhuri (of the Essex Centre for Neurosciences) spoke on “A rational, efficient and practical approach to diagnosis”. He said that ‘CFS’ represents a wide group of patients and the term does not help matters; that there should be earlier diagnosis, perhaps three months into illness onset (six weeks where children are concerned). He does not think the NICE Guideline has helped. In his view, post-exertional malaise, muscle cramps and *well preserved motivation and interest* (my emphasis) are key symptoms of M.E. and referral should be to a neurologist, since even psychiatrists admit that roughly 10% of ‘CFS’ sufferers have a neurological problem. He said that we need a national centre and funding for it (Romford being a treatment – not research – centre). His talk ended with a slide presentation of inflammation of the dorsal root ganglion, which he pointed out was “the gatekeeper of sensations”.

In the question slot Ciaran Farrell asked how we could change the NHS – to much applause from the audience. Dr Chaudhuri repeated that we need a national research centre.

“M.E. in children and adolescents” was presented by Shannen Dabson, a teenager whose story struck a particular chord with me as a teacher (prior to M.E.). She has had M.E. for six years, and now has very little trust in adults, having received virtually no respect for herself and her diagnosis. She found herself “written off” by her school, who didn’t send her work, didn’t mark the work she managed to do, didn’t send her the school newsletters or keep her informed of such things as the school photographs (which was the part that had me closest to tears, as I’d suffered the same treatment from my last employer: I will never forgive them for my absence from the school photograph of my form pupils; for both Shannen and me, it was like being airbrushed out of history). Shannen had had to make her own arrangements for taking exams, as her school refused to enter her on the grounds of a poor attendance record. To her admirable credit, she got six GCSEs anyway! I’m hoping to reproduce her talk for “MES-N” members, as it should be inspirational, especially for youngsters. She came up with what I personally consider to be a very practical, appropriate and *scientifically sound* slogan: “Work smarter, not harder!”

Hardip Begol (of the Department for Children, Schools and Families) spoke on “Addressing the educational impact of ME”, and said that Shannen’s situation is all too common from an educational point of view and that it was difficult to make teachers believe in ME/CFS. No personal disrespect to Mr Begol, but it struck me that what he had to say in his presentation did not have all that much immediate relevance, being, as one might expect, current government ‘fudge’. His comments were not actually specific to M.E., but here’s hoping that the conference gave him something to think about and take back to the DfCSF (though I’m not really holding my breath on that one).

In the question slot following these two talks Mary-Jane Willows (of AYME) said that the balance of power was with schools and Jane Colby pointed out that parents are too afraid to complain. (Personal note – no wonder, with the spectre of Social Services waiting in the wings, ready to pounce.)

Catriona Courtier (of the West London M.E. Self Help Group) spoke on “Treatment: the patient’s perspective”. She has had M.E. for twenty six years and her daughter is also ill. She reminded us that an AfME survey revealed that patients received very little proper treatment and that an MEA survey demonstrated that graded exercise therapy (GET) was the most dangerous form. She is ‘anti-NICE’. She said that staff at her local clinic *want* to help – but are misinformed.

Prof Anthony Pinching of the Peninsula Medical School, Plymouth, spoke on “Treatment – evidence-based and pragmatic approaches” and thinks that things are changing for the better. In his view, M.E. is a physical illness with psychological consequences and that people should work together and “not lob bricks at each other”. He said that the Cornwall service does make home visits. He advocates a ‘symptom-control’ approach: which symptoms does a patient want most help with? I found him to be a bit vague and general, really, and he seemed to be saying that every individual needs different treatment (including psychological approaches), to be negotiated between patient and physician, and seemed to imply that success depended on the doctor-client relationship (which I personally find a bit too New-Agey: “permission to be ill and permission to have fun whilst you’re ill”). He did, however, say that there is a need for “building M.E. into the medical curriculum” (note – although it depends on exactly *what* is built in!). In response to a question about CBT from Dr Charles Shepherd, he indicated that such treatment should be ‘individualised’.

In the question slot Dr Chaudhuri expressed disagreement with Prof Pinching, saying that patients are *not* listened to and that the NICE Guideline is aimed at a *broad* group – these points being applauded by the audience. Prof Pinching responded that the NICE Guideline is not perfect, but should be used “to best effect”.

After a short (very short!) break, Sir Peter Spencer (Chief Executive Officer, AfME) chaired Session 2.

Dr Neil Abbott (ME Research UK) spoke on “Research: what do patients want and why isn’t it happening?” He suggested that the RSM host a biomedical conference on M.E. (Applause!) He said that the psychosocial model is predominant in the UK, although not quite so much in the US. He quoted Prof Simon Wessely with reference to psychosocial interventions: “certainly, those interventions are not the answer to CFS”. MERUK survey reveals that research on mitochondria, RBCs, immune cells, muscles, blood vessels, genes and brain are wanted; that this is not “sexy” illness. ‘ME/CFS’ label is a problem: it is a process of elimination and that leads to a dustbin diagnosis. He is critical of the psychosocial approach, which is applicable to *all* illnesses (used to manage symptoms) and not specific to M.E. The real problem, in his view, is lack of funding.

Prof Stephen Holgate (University of Southampton) spoke on “ME: a research orphan for too long”. He said we need research because too little is known [sic] and said that the history of M.E. has dictated a mental health approach, it being perceived as having evolved from neurasthenia [‘nervous debility’]. He said, “It’s a system disorder” and that ‘omics’ should be used – i.e. genomics, proteomics and metabolomics. He referred to ‘ME/CFS’ as a “condition or conditions (25 or more)”; that the government won’t allow integrated research. He is putting together a workshop in November (the Medical Research Council Interdisciplinary Expert Group on M.E.), a systematic review deciding priorities, saying that a collaborative needs to be formed from charities [sic], the MRC and researchers, and that there is a need to ‘join up’ patients from clinics/centres. [Personal note: it all seemed to me a bit like reinventing the wheel and I have my misgivings about not only which ‘charities’ will be invited to participate but also the calibre of patients from the clinics/services.]

Dr David Misselbrook (Dean of the RSM) then invited questions to the panel of speakers. An elderly neuroscientist and his grandson tried to deliver a plug for the Lightning Process, the grandson claiming we had “wasted all this time talking when a cure has already been found” [sic], but Dan [from “M.E. Support-Norfolk”] pointed out that we hadn’t come all this way to hear a sales pitch for LP and Jane Colby expressed serious misgivings about success claims, citing an example of further harm caused to a patient; she also pointed out that no one can legally claim recompense if LP doesn’t cure a patient as it is not offered as a treatment, but a ‘training’.

Ciaran Farrell challenged Prof Holgate’s ‘history’ of M.E. but Prof Holgate said he had been misunderstood, that it wasn’t his own belief that M.E. was a form of neurasthenia and that he agreed with Ciaran, adding that he wanted to get rid of the terms “CFS” and “M.E.” [whatever that implies!].

In “Closing remarks”, Mary-Jane Willows said that there should be quick diagnosis, raising of awareness and no “one size-fits-all” approach. Doris Jones (of the 25% ME Group) read out a list of M.E. sufferers who have died and requested a minute’s silence in their memory, which was dutifully observed.

All in all, in my own opinion? A worthwhile day in order to find out what is going on in various quarters, but throughout the proceedings I did wonder who the ‘target audience’ was supposed to be, and for whose benefit this had all been arranged. Was it a ‘box-ticking’, ‘patient consultation’ exercise? The subtitle of the event, “Hearing the patient voice”, was a bit misleading, since we were mostly being talked at, not listened to; there certainly wasn’t enough time, as I said at the beginning, for much questioning or discussion. But maybe some of what was said will pay dividends. Fingers crossed.

John Sayer, Chair
M.E. Support-Norfolk

————————-

Ed Notes:

1] Terms of Reference for the MRC’s Interdisciplinary Expert Group on M.E. have yet to be agreed (FOI Act).

2] ME agenda is unable to enter into correspondence around the Lightning Process.

Invest in ME: Statement regarding Forward-ME

The Minutes of the last meeting of the Forward-ME group (a caucus group to the APPG on ME, convened and chaired by the Countess of Mar) held on Wednesday 8 July, at the House of Lords, can be read here on ME agenda or here on the website of Forward-ME.

Invest in ME, who are members of this group, have issued a statement in connection with Forward-ME and the last meeting of the group:

Invest in ME

[Forward-ME] Meeting 8th July 2009

IiME were not able to attend the meeting of this group on 8th July 2009 in London. As for every other meeting we submitted our comments to the Countess of Mar and all other members of this group in advance.

1 Attendance at Meetings and Visibility of Comments

We would like to return to our previous email (submitted in an email on 12th December 2008) where we stated the following –

We understand that, as we were unable to attend the last meeting, any decisions made at the meeting would not include our vote.

However, we see no reference in the minutes of either of the meetings to show that our views, as submitted in documentary form prior to each of the meetings, have been discussed or included in the discussions.

We would like to see that our comments have been entered into the discussions. Will the minutes reflect this?

We never received any response from our email of 23rd March.

2 GOSH medical meeting on ME/CFS in September to be discussed and the subject of Lightning Process

In the next meeting the subject of the GOSH at a day long medical meeting on ME/CFS in September is to be discussed and the subject of Lightning Process.

Mary-Jane from AYME has written “I share your concerns about this (LP) being included in the meeting”

We find this strange and hypocritical.

AYME have advertised LP for its members and freely allow discussion without seemingly making any critical comment on the lack of a research base, the numerous cases where people have been made worse and the fact that the practitioners of LP are generally not registered healthcare practitioners and take no responsibility for the results.

To state that there are concerns seems to us to be hypocrisy.

One should also remember that AYME and AfME are not in a position to criticise GOSH for including behavioural therapies/businesses as most of their recent joint conference in Milton Keynes included known advocates of the behavioural causality for ME and also included an insurance company representative.

3 Questions for Esther Crawley CNRCC Children’s Services

We have the following questions for Esther Crawley.

In your CV it states that you published research showing “children with CFS/ME don’t go to school because they are unwell not anxious”. However, isn’t it true that you believe there is a condition termed Pervasive Refusal Syndrome (PRS)?

If the answer to i) is yes then what proof do you have of this, what research is there to prove this really exists?

If the answer to i) is yes then how many children who were diagnosed with ME have you believed to have PRS?

What medical tests do you perform on patients who are suspected of having ME/have ME?

Do you test for acute and/or reactivated infections?

From the minutes of the meeting it appears none of our points were discussed. IiME were informed by CoM [Countess of Mar] that the questions to Esther Crawley were not asked as they were not appropriate to the discussion. The minutes of that meeting are available here

Ends

——————-

Please note that ME agenda is unable to enter into correspondence around the Lightning Process. Please direct any enquiries regarding the content of the Minutes of Forward-ME meetings to the Chair of Forward-ME. Please direct any enquiries regarding the content of Invest in ME’s statement to Invest in ME.

Documented pathology seen in ME/CFS that contra-indicates the use of GET: Margaret Williams 23 July 2009

Documented pathology seen in ME/CFS that contra-indicates the use of Graded Exercise Therapy

by Margaret Williams

23 July 2009

This document together with previous articles and commentaries by Margaret Williams can be found at ME Action UK

http://www.meactionuk.org.uk/Documented_pathology_seen_in_ME-CFS.htm

http://www.meactionuk.org.uk/Documented_pathology_seen_in_ME-CFS.pdf

The evidence-base of pathology that has been demonstrated in ME/CFS appears within a larger document that is already in the public domain, but is now provided as a 9 page separate item for ease of access.

The UK ME/CFS community may not yet be fully aware of the content of Dr Esther Crawley’s presentation on 8th July 2009 to the Countess of Mar’s “Forward-ME” group meeting held at the House of Lords. The Minutes of that meeting and Dr Crawley’s power-point presentation are accessible at http://www.forward-me.org.uk/8th%20July%202009.htm

Of particular note are the following points made by Dr Crawley:

· The CCRNC (CFS/ME Clinical and Research Network and Collaboration, of which she is Chair) is a “multidisciplinary organisation which exists to promote and support the delivery of evidenced based treatment for children, young people and adults with CFS/ME throughout the UK” whose objective is “To champion evidence-based approaches to the treatment of CFS/ME, such as those provided in the NICE guidelines” and which will use “clinical expertise to inform healthcare policy” and will “provide training for clinicians and researchers from all disciplines involved in the diagnosis and treatment of CFS/ME”.

· The CCRNC has an “Active training programme” and has “the ability to provide national training programmes”.

· The CCRNC will “invite no more than four people drawn from National UK CFS/ME organisations which explicitly support the aims and constitution of the organisation to sit on the Executive committee as either observers or members”.

· Its research strength is that it has the “Largest cohort in the world”.

· Its strengths are “working together — 600 clinicians and researchers, MRC, NIHR (National Institute for Health Research), Welcome (sic), patient and carer reps, charity membership”.

It is particularly notable that the Minutes record that when asked by Dr Charles Shepherd “whether, in the light of the widespread opposition to the NICE Guidelines, charities that were opposed to them would be invited to become members or associates of the CCRNC executive”, Dr Crawley’s response was: “In order to join the collaborative, charities would be expected to sign up to the evidence-based approach”.

The only possible interpretation of this is that patients’ charities are welcome to participate provided that they accept the behavioural modification interventions of CBT/GET recommended in the NICE Guideline (for which Dr Crawley was a member of the Guideline Development Group).

This would seem to be something akin to medical totalitarianism, especially given that Wessely School “evidence-base” upon which the NICE Guideline is predicated has been so stringently criticised by international ME/CFS experts.

See, for example: http://www.meactionuk.org.uk/JR_Statements_-_extracts.htm

It is worth recalling that at the Royal Society of Medicine meeting on “Medicine and me: ME and CFS” held just three days later on 11th July 2009, MRC Professor of Clinical Immunopharmacology Stephen Holgate said that at the MRC, referees tend to reinforce the status quo and that he was not sure if his wish for an MRC inter-disciplinary group involving immunologists, neurologists and infectious diseases physicians would happen, which would seem to indicate that the psychiatrists’ stranglehold on MRC funding for biomedical research into ME/CFS is set to continue.

The Forward-ME Minutes also record that Dr Crawley said: “the reputation the CFS/ME charities had for infighting was not particularly helpful and prevented research and clinical involvement”.

Given that the “infighting” may have arisen because of the polarised views about the nature of ME/CFS, with the Government-funded charities (Action for ME and The Association of Young People with ME, to the latter of which Dr Crawley is Medical Advisor) supporting the NICE Guideline that is underpinned by flawed research, whilst other charities base their stance on the international evidence that shows the NICE Guideline to be seriously misinformed, it may be timely to look again at the following “evidence-base”.

Dr. Crawley stated that only those ME/CFS charities which agree to “sign up to the evidence based approach” are to be permitted to join her “collaborative”.

Given the volume of biomedical evidence that does not support Graded Exercise Therapy it would appear that in this instance signing up to an “evidence based approach” involves signing up to an approach that ignores most of the evidence.

Science is not furthered by a self-reinforcing “collaborative” determined to exclude dissenting voices; rather, a vigorous and honest dialectic is required. Medicine has no place for cabals and the lazy thinking they foster.

The “Forward-ME” Minutes record that Lady Mar said she hoped that Dr Crawley would “agree to continue to work with Forward-ME”; one can only wonder, sadly, just how far backwards her “Forward-ME” initiative will carry the UK ME/CFS community.

Evidence-based research showing pathology that contra-indicates the use of graded exercise in ME/CFS

There is an extensive literature from 1956 to date on the significant pathology that has been repeatedly demonstrated in ME/CFS, but not in “CFS/ME” or “chronic fatigue”; this can be accessed on the ME Research UK website at

http://www.meresearch.org.uk/information/researchdbase/index.html and also at http://www.meactionuk.org.uk/Organic_evidence_for_Gibson.htm

According to Professor Nancy Klimas, ME/CFS can be as severe as congestive heart failure and the most important symptom of all is post-exertional relapse (presentation at the ME Research UK International Conference held in Cambridge in May 2008). Continue reading “Documented pathology seen in ME/CFS that contra-indicates the use of GET: Margaret Williams 23 July 2009” →

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